UNITRON MODEL SOUND F/X CIC
Device Facts
| Record ID | K970692 |
|---|---|
| Device Name | UNITRON MODEL SOUND F/X CIC |
| Applicant | Unitron Industries, Inc. |
| Product Code | ESD · Ear, Nose, Throat |
| Decision Date | May 8, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
To amplify and transmit sound via air conduction to the ear.
Device Story
Completely-In-The-Canal (CIC) hearing aid; amplifies/transmits sound via air conduction. Features two-channel wide dynamic range compression; six adjustable parameters (Low/High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point, power); twin average compression detectors; Class D circuitry. Powered by size 10A or 5A battery. Operated by patient; volume adjusted via screw set control. Assembled from standard industry components. Benefits patient by improving auditory perception.
Clinical Evidence
Bench testing only; compliance with ANSI Standard S3.22-1987.
Technological Characteristics
CIC form factor; Class D circuitry; two-channel wide dynamic range compression; six adjustable parameters; screw set volume control; powered by size 10A or 5A batteries. Technical specifications comply with ANSI S3.22-1987.
Indications for Use
Indicated for individuals requiring sound amplification via air conduction to the ear to address hearing impairment.
Regulatory Classification
Identification
An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.
